K-number	K963631
Device name	SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
Applicant	Omega Results
Product code	OLZ
Device class	Class II
Decision date	Apr 2, 1997
Decision	Substantially Equivalent
Regulation	882.1400

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View the full FDA submission: accessdata.fda.gov

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SLEEP STUDY ANALYSIS (SSA) VERSION 96.10

Everything you need for a 510(k) submission. Nothing you don't.